COVID-19 Clinical Trials and Expanded Access

Acute Respiratory Distress Syndrome (ARDS) reflects the hallmark of the critical courseof coronavirus (COVID19). The investigators have recently shown that Exhaled BreathParticles (EBP) measured as particle flow rate (PFR) from the airways could be used as anoninvasive real-time early detection method for primary graft dysfunction (which bears apathophysiological resemblance to ARDS) in lung transplant patients. The investigatorshave also previously demonstrated the utility of PFR in early detection and monitoring ofARDS in a large animal model. PFR has been shown to be elevated prior to the cytokinestorm which classically occurs in ARDS. Early detection of ALI and ARDS is intimatelylinked to a patient's chance of survival as early treatment consisting of the preparationfor intensive care, prone positioning and protective mechanical ventilation can beimplemented early in the process. In the present study the investigators aim to usereal-time PFR as an early detector for COVID19-induced ARDS. The investigators will alsocollect EBPs onto a membrane for subsequent molecular analysis. Previous studies haveshown that most of those proteins found in bronchoalveolar lavage (BAL) can also bedetected in EBPs deposited on membranes. The investigators therefore also aim to be ableto diagnose COVID19 by analyzing EBPs using Polymerase Chain Reaction (PCR) with the samespecificity as PCR from BAL, with the added benefit of being able to identify proteinbiomarkers for early detection of ARDS.

Preliminary reports have been received from several sources that the periodic inhaling ofthe nebulized mist from water that has a heightened level of kinetic activity has quickly(less than 2 days) lessened the severity of symptoms in Covid-19 infected patients. On atleast several occasions, a repeat PCR test performed several after inhaling a particularwater-based product was negative. There are no perceived adverse effects from inhalingthe water mist by using a nebulizer or humidifier. It is important, however, to validatethese preliminary findings and to include the inhaling of the mist from water, which doesnot have an elevated level of kinetic activity. This will be by performed in apatient-blinded manner by sequentially inhaling the two types of water over consecutive2-day periods with Covid-19 testing at the end of each of the two day periods.Participants will be randomized as to whether they are to inhale the mist from the testor the control water.

This study investigates the impact of the COVID-19 pandemic on the psychosocial health ofemployees of MD Anderson Cancer Center. Epidemics have been shown to promotepsychological stress among medical staff in high risk areas, which may lead to mentalhealth problems. Assessing how the pandemic is affecting employees may allow for morecomprehensive actions to be taken to protect the mental health of employees.

A Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viralpneumonia that can lead to respiratory distress requiring resuscitation. In the mostsevere forms, it may require mechanical ventilation or even lead to an acute respiratorydistress syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-strandedRNA virus of positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2is responsible for the third epidemic in less than twenty years secondary to aCoronavirus (SARS-CoV then MERS-CoV) and if the mortality associated with it is lowerthan that of previous strains, notably MERS-CoV, its spread is considerably big. As aresult, the number of patients developing respiratory distress requiring invasivemechanical ventilation is high, with prolonged ventilation duration in these situations

COVID-19 is the pandemic disease caused by the SARS-CoV-2 coronavirus. It is a highlycontagious viral disease, the condition of which main clinical symptoms are characterizedby fever and respiratory symptoms. Evidence indicates to worse outcomes in patients withpre-existing diseases, such as diabetes, arterial hypertension, heart disease,pneumopathies, chronic kidney disease, and immunodeficiencies. Recipients of kidneytransplants make prolonged use of immunosuppressive drugs to inhibit the acquired immuneresponse, notably the activity of lymphocytes. Due to this potential to modulate theimmune and inflammatory response, it is speculated that the clinical and laboratorycondition of COVID-19 in these patients is atypical. Preliminary evidence suggests worseoutcomes of COVID-19 in immunosuppressed patients, as carriers of cancer. However,information on kidney transplant recipients is insufficient. So far, only reports of thecase are available in the literature with different clinical presentations and outcomes.The aim of this study is, therefore, to characterize the demographics, clinical andlaboratory conditions, and the outcomes of COVID-19 in kidney transplant recipients in anational multicenter cohort.

This phase I trial investigates breathing techniques and meditation for health careworkers during COVID-19 pandemic. Breathing techniques and medication may help managestress and improve lung health. The goal of this trial is to learn if breathingtechniques and meditation may help to reduce stress and improve lung health in healthcare workers during the COVID-19 pandemic.

The purpose of this study is to evaluate how useful vitamin D supplementation is inreducing the severity of COVID-19 symptoms and the body's inflammatory andinfection-fighting response to COVID-19. Individuals ≥50 years of age and older who aretested for COVID-19 and negative will be randomized (like flipping a coin) to eitherdaily high dose vitamin D supplementation (6000 IU vitamin D3/day) vs. standard of care.Those individuals ≥50 years of age or older who test positive for COVID-19 at baselinewill be randomized to bolus vitamin D (20,000 IU/day for 3 days) followed by high dose(6000 IU vitamin D/day) vs. standard of care for 12 months. All participants will receivea multivitamin containing vitamin D.

Postpartum depression (PPD) represent around 15% of birth in developed countries. Thecontext of the COVID-19 epidemy represents a possible source of additional emotionaldistress. The objective of this study is to determine the screening prevalence and riskfactors of postpartum depression, among women who deliver in fourth hospital in the Northof France in the context of the COVID epidemy.

This is a randomized, double-blinded, placebo-controlled, two-arm study to evaluate thesafety and efficacy of BIO 300 Oral Suspension (BIO 300) as a therapy to improve lungfunction in patients that were hospitalized for severe COVID-19-related illness andcontinue to experience post-acute respiratory complications associated with Long-COVIDafter discharge. Patients will be randomized 1:1 to receive BIO 300 or placebo.

Recent studies have shown that some individuals may be asymptomatic but continue to shedthe COVID-19 virus. These individuals may represent a population that can unknowinglytransmit the virus. Healthcare workers (HCW) may acquire COVID-19 from the community orfrom possibly infected patients. It is important to gather data with respect to this tofurther understand the prevalence of asymptomatic carriage in individuals who work inresearch facilities, offices and clinical areas of hospitals and researchfacilities/institutes since this has important implications for infection control, aswell as staff and patient safety. The purpose of this study is to test whether aproportion of these individuals may be asymptomatic shedders of the COVID-19 virus.